Trial Outcomes & Findings for Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma (NCT NCT03215758)
NCT ID: NCT03215758
Last Updated: 2026-01-13
Results Overview
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.
COMPLETED
PHASE3
675 participants
Week 12
2026-01-13
Participant Flow
Participants were recruited from centers in Argentina (20), Germany (12), Hungary (4), Mexico (2), Philippines (4), Slovakia (7), South Africa (5), Turkey (5), United States (29)
Participant milestones
| Measure |
QAW039
QAW039 once daily
|
Placebo
Placebo once daily
|
|---|---|---|
|
Overall Study
STARTED
|
339
|
336
|
|
Overall Study
COMPLETED
|
334
|
328
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
QAW039
QAW039 once daily
|
Placebo
Placebo once daily
|
|---|---|---|
|
Overall Study
Technical Problems
|
1
|
0
|
|
Overall Study
Protocol deviation
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Subject/Guardian Decision
|
3
|
3
|
Baseline Characteristics
Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
Baseline characteristics by cohort
| Measure |
QAW039
n=339 Participants
QAW039 once daily
|
Placebo
n=336 Participants
Placebo once daily
|
Total
n=675 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.1 Years
STANDARD_DEVIATION 15.15 • n=210 Participants
|
47.7 Years
STANDARD_DEVIATION 15.40 • n=19 Participants
|
47.9 Years
STANDARD_DEVIATION 15.26 • n=123 Participants
|
|
Sex: Female, Male
Female
|
217 Participants
n=210 Participants
|
216 Participants
n=19 Participants
|
433 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=210 Participants
|
120 Participants
n=19 Participants
|
242 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
274 Participants
n=210 Participants
|
281 Participants
n=19 Participants
|
555 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Black
|
18 Participants
n=210 Participants
|
12 Participants
n=19 Participants
|
30 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Asian
|
39 Participants
n=210 Participants
|
34 Participants
n=19 Participants
|
73 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
2 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=210 Participants
|
3 Participants
n=19 Participants
|
3 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=210 Participants
|
6 Participants
n=19 Participants
|
11 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Full analysis set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.
Outcome measures
| Measure |
QAW039
n=339 Participants
QAW039 once daily
|
Placebo
n=336 Participants
Placebo once daily
|
|---|---|---|
|
Change From Baseline in Pre-dose FEV1 at Week 12
|
0.112 Liters
Standard Error 0.0167
|
0.071 Liters
Standard Error 0.0169
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.
Daytime asthma symptoms are evaluated through four questions and each of them will be rated on a scale of 0 to 6. Higher scores indicate more severe asthma-related symptoms. A mean score will be calculated for the responses to 4 questions.
Outcome measures
| Measure |
QAW039
n=339 Participants
QAW039 once daily
|
Placebo
n=336 Participants
Placebo once daily
|
|---|---|---|
|
Change From Baseline in Daytime Asthma Symptom Score
|
-0.56 Score
Standard Error 0.036
|
-0.51 Score
Standard Error 0.037
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.
Daily use of SABA (the number of rescue medication puffs taken in the previous 12 hours) was recorded using a patient electronic diary (referred to as eDiary or eDiary/ePEF). Patients were instructed to routinely complete the patient diary twice daily - at the same time each morning and each evening, approximately 12 hours apart.
Outcome measures
| Measure |
QAW039
n=339 Participants
QAW039 once daily
|
Placebo
n=336 Participants
Placebo once daily
|
|---|---|---|
|
Change From Baseline in Daily Use of SABA
|
-1.11 Number of puffs
Standard Error 0.075
|
-1.02 Number of puffs
Standard Error 0.076
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.
AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses.
Outcome measures
| Measure |
QAW039
n=339 Participants
QAW039 once daily
|
Placebo
n=336 Participants
Placebo once daily
|
|---|---|---|
|
Change From Baseline in Asthma Quality of Life (AQLQ+12) Score
|
0.91 units on a scale
Standard Error 0.048
|
0.89 units on a scale
Standard Error 0.049
|
Adverse Events
QAW039 150 mg
Placebo
Serious adverse events
| Measure |
QAW039 150 mg
n=339 participants at risk
QAW039 150 mg
|
Placebo
n=336 participants at risk
Placebo
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/339 • After signing informed consent to 30 days after last dose
|
0.30%
1/336 • After signing informed consent to 30 days after last dose
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/339 • After signing informed consent to 30 days after last dose
|
0.30%
1/336 • After signing informed consent to 30 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.00%
0/339 • After signing informed consent to 30 days after last dose
|
0.30%
1/336 • After signing informed consent to 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.29%
1/339 • After signing informed consent to 30 days after last dose
|
0.60%
2/336 • After signing informed consent to 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/339 • After signing informed consent to 30 days after last dose
|
0.30%
1/336 • After signing informed consent to 30 days after last dose
|
Other adverse events
| Measure |
QAW039 150 mg
n=339 participants at risk
QAW039 150 mg
|
Placebo
n=336 participants at risk
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.59%
2/339 • After signing informed consent to 30 days after last dose
|
1.2%
4/336 • After signing informed consent to 30 days after last dose
|
|
General disorders
Fatigue
|
0.59%
2/339 • After signing informed consent to 30 days after last dose
|
1.2%
4/336 • After signing informed consent to 30 days after last dose
|
|
Infections and infestations
Acute sinusitis
|
1.2%
4/339 • After signing informed consent to 30 days after last dose
|
0.30%
1/336 • After signing informed consent to 30 days after last dose
|
|
Infections and infestations
Bronchitis
|
3.5%
12/339 • After signing informed consent to 30 days after last dose
|
3.0%
10/336 • After signing informed consent to 30 days after last dose
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
13/339 • After signing informed consent to 30 days after last dose
|
3.6%
12/336 • After signing informed consent to 30 days after last dose
|
|
Infections and infestations
Rhinitis
|
0.29%
1/339 • After signing informed consent to 30 days after last dose
|
1.5%
5/336 • After signing informed consent to 30 days after last dose
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
6/339 • After signing informed consent to 30 days after last dose
|
3.0%
10/336 • After signing informed consent to 30 days after last dose
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
1.5%
5/339 • After signing informed consent to 30 days after last dose
|
1.5%
5/336 • After signing informed consent to 30 days after last dose
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.1%
7/339 • After signing informed consent to 30 days after last dose
|
1.8%
6/336 • After signing informed consent to 30 days after last dose
|
|
Investigations
Blood creatine phosphokinase increased
|
0.59%
2/339 • After signing informed consent to 30 days after last dose
|
1.5%
5/336 • After signing informed consent to 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.29%
1/339 • After signing informed consent to 30 days after last dose
|
1.2%
4/336 • After signing informed consent to 30 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
4/339 • After signing informed consent to 30 days after last dose
|
1.2%
4/336 • After signing informed consent to 30 days after last dose
|
|
Nervous system disorders
Headache
|
1.8%
6/339 • After signing informed consent to 30 days after last dose
|
2.1%
7/336 • After signing informed consent to 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
12.7%
43/339 • After signing informed consent to 30 days after last dose
|
13.4%
45/336 • After signing informed consent to 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.59%
2/339 • After signing informed consent to 30 days after last dose
|
1.5%
5/336 • After signing informed consent to 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/339 • After signing informed consent to 30 days after last dose
|
1.2%
4/336 • After signing informed consent to 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.5%
12/339 • After signing informed consent to 30 days after last dose
|
1.8%
6/336 • After signing informed consent to 30 days after last dose
|
|
Vascular disorders
Hypertension
|
0.29%
1/339 • After signing informed consent to 30 days after last dose
|
1.5%
5/336 • After signing informed consent to 30 days after last dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER